Tag Archive: PDUFA

Dec 19

FDA: The Year in Review (2012)

On 10 Dec 2012, the FDA released a report titled, “FY 2012 Innovative Drug Approvals,” which discusses the FDA’s 2012 novel drug approvals and the focus on the advancement of regulatory science in to improve the drug approval process. Thirty-five novel drugs were approved by the FDA in 2012, matching the number of approvals in …

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Aug 15

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 20

FDASIA, Part 1: The “UFAs”

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part series, we will cover the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical Device Regulatory …

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Jul 16

New Provisions in the FDA Safety and Innovation Act (aka PDUFA V)

Seal of the U.S. Congress

On 09 July 2012, President Obama signed FDASIA (otherwise known as PDUFA V) into law. The reauthorization of PDUFA V has been working its way through both houses of Congress since May and has received uncharacteristically broad bipartisan and bicameral support. In 2007, PDUFA IV was hotly debated between the two chambers and was barely passed in time to replace the expiring PDUFA III, but this time, lawmakers were able to meet their goal of sending the President a reconciled bill well before the 30 September expiration date of PDUFA IV.

The new law will go into effect on 01 Oct 2012 and will sunset on 30 Sept 2017.

The FDASIA includes the following provisions

May 25

PDUFA V: A Funny Sounding Name for a Very Important Bill (Updated!)

US Capitol

Can you say PDUFA (pŭ-dōō-fŭ)?  The United States Senate can.  A very partisan Senate showed uncharacteristically bipartisan support for the Prescription Drug and User Fee Act (PDUFA) V, voting on 24 May 2012 to reauthorize PDUFA by a 96 to 1 vote.  This reauthorization allows for a 6% increase in fees paid by drug and …

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Oct 06

September 2010 FDA Guidances

Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in September 2010 (links go directly to PDF documents). Special Interest Guidances/Information Date Posted Safety Reporting Requirements for INDs and BA/BE Studies (Draft) 09/28/2010 Suicidality: …

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Apr 27

The Road to PDUFA V

The road to success is always under construction. – Lily Tomlin At three years into the fourth iteration of the Prescription Drug User Fee Act (PDUFA), it’s time to start looking down the road towards PDFUA’s reauthorization (which will be PDUFA V).  Time flies, no? The FDA held a meeting earlier this month to gather public …

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